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FAQs

Find below the most frequently asked questions regarding transcatheter aortic valve implantation (TAVI). If you have a question regarding TAVI that is not answered below, please contact us at: hospitalhealthcare@edwards.com.

Aortic stenosis is a thickening or calcification of the heart valve in the aorta, which means that the valve leaflets no longer open and close properly. Over time, the diseased valve leaflets don’t open as wide as they should, and as the valve opening narrows, the heart is less able to pump blood around the body effectively. If, left untreated, this can lead to signs of heart failure.1

Reference

  1. NHS. Diagnosis and treatment: aortic stenosis. 2014. Available from: https://www.uhs.nhs.uk/OurServices/Bloodandcirculation/Transcatheter-aortic-valve-implantation/Diagnosis-and-treatment-TAVI/Diagnosis-and-treatment-TAVI.aspx

Aortic stenosis is the most common valvular heart disease in developed countries. It presents in 1.4% of the population aged ≥65 years, which rises to 4.1-5.2% in the population aged ≥75 years.1 By 2050, the prevalence of aortic stenosis is expected to double; the progressive ageing of the population is anticipated to increase the impact of aortic stenosis on health institutions.2

References

  1. Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. The Lancet 2006;368:1005-1011.
  2. d’Arcy JL, Coffey S, Loudon MA, et al. Large-scale community echocardiographic screening reveals a major burden of undiagnosed valvular heart disease in older people: the OxVALVE Population Cohort Study. Eur Heart J 2016;37:3515-3522.

Aortic stenosis can be categorised as mild, moderate or severe, depending on the damage to the aortic valve and accompanying symptoms.1 If no symptoms are present, patients are placed under watchful waiting and are advised to maintain a healthy lifestyle.1,2 To compensate for the decreased efficiency of the heart, the muscle enlarges (termed ventricular hypertrophy). As stenosis worsens, this compensatory mechanism becomes inadequate, which can lead to noticeable symptoms, some of which are indicative of pulmonary oedema or heart failure.3

References

  1. WebMD. What Is Aortic Valve Stenosis? 2019. Available from: https://www.webmd.com/heart-disease/aortic-valve-stenosis. Accessed June 2021.
  2. Grimard BH, Larson JM, Clinic M, et al. Aortic Stenosis: Diagnosis and Treatment. Aortic Stenosis 2008;78:8.
  3. Zakkar M, Bryan AJ, Angelini GD. Aortic stenosis: diagnosis and management. BMJ 2016:i5425.

Patients often report symptoms that are linked to heart failure or pulmonary oedema, such as fatigue, shortness of breath, chest pain, heart palpitations, dizziness, syncope, or oedema of the feet and ankles.1,2

References

  1. Zakkar M, Bryan AJ, Angelini GD. Aortic stenosis: diagnosis and management. BMJ 2016:i5425.
  2. Heart Valve Voice. Aortic Stenosis. Available from: https://heartvalvevoice.com/heart-valve-disease/the-condition/aortic-stenosis. Accessed June 2021.

For severe symptomatic aortic stenosis, aortic valve replacement (AVR) should be recommended, which can include surgical repair or a less invasive procedure such as transcatheter aortic valve implantation (TAVI).1,2,3

References

  1. NHS. Diagnosis and treatment: aortic stenosis. 2014. Available from: https://www.uhs.nhs.uk/OurServices/Bloodandcirculation/Transcatheter-aortic-valve-implantation/Diagnosis-and-treatment-TAVI/Diagnosis-and-treatment-TAVI.aspx. Accessed June 2021.
  2. WebMD. What Is Aortic Valve Stenosis? 2019. Available from: https://www.webmd.com/heart-disease/aortic-valve-stenosis. Accessed June 2021
  3. Zakkar M, Bryan AJ, Angelini GD. Aortic stenosis: diagnosis and management. BMJ 2016:i5425.

Without treatment, prognosis is poor with a 3-year survival rate <30%. However, it is estimated that 33% of patients aged ≥75 years are declined for treatment, even when indicated. Moreover, many older patients are deemed to be of prohibitive risk for surgical aortic valve replacement (SAVR): instead, patients with ssAS can be considered for transcatheter aortic valve implantation (TAVI).1,2

References

  1. Spaccarotella C, Mongiardo A, Indolfi C. Pathophysiology of Aortic Stenosis and Approach to Treatment With Percutaneous Valve Implantation. Circ J 2011;75:11-19.
  2. Osnabrugge RLJ, Mylotte D, Head SJ, et al. Aortic Stenosis in the Elderly. J Am Coll Cardiol 2013;62:1002-1012.

TAVI is a procedure by which an artificial valve is placed in the heart. This is done by introducing a catheter through a small cut in the groin (transfemoral TAVI) or via the left-hand side of the chest (transapical TAVI). The valve, which sits inside a stent is crimped onto the end of the catheter, and when in place, a small balloon is inflated, which allows the valve to expand. Once expanded, the new valve displaces the native valve leaflets outward and takes over the regulation of blood flow across the aortic valve.1,2,3

References

  1. NHS. Diagnosis and treatment: aortic stenosis. 2014. Available from: https://www.uhs.nhs.uk/OurServices/Bloodandcirculation/Transcatheter-aortic-valve-implantation/Diagnosis-and-treatment-TAVI/Diagnosis-and-treatment-TAVI.aspx. Accessed June 2021.
  2. Zakkar M, Bryan AJ, Angelini GD. Aortic stenosis: diagnosis and management. BMJ 2016:i5425.
  3. NHS. Transcatheter aortic valve implantation (TAVI) procedure. 2020. Available from: https://www.kch.nhs.uk/Doc/pl%20-%20859.3%20-%20transcatheter%20aortic%20valve%20implantation%20(tavi)%20procedure.pdf. Accessed June 2021.

Reportedly, there are 115,000 eligible ssAS candidates for TAVI who are deemed inoperable or of high- and intermediate-risk across the EU,1 and numerous prospective trials and observational studies have reported improved survival of TAVI compared with SAVR in prohibitive2, high3, intermediate4 and low5 surgical risk patients with ssAS.

With an ever-increasing ssAS population becoming eligible for TAVI, the uptake of TAVI across the EU is expected to increase to as much as 177,000 with major implications for healthcare resource planning.1

Additionally, the ongoing COVID-19 pandemic is undoubtedly adding to the increasing ssAS patient population who are eligible for TAVI: it has been reported that during the peak of the pandemic, ssAS patients who were previously accepted for SAVR were being reconsidered for TAVI.6

References

  1. Durko AP, Osnabrugge RL, Van Mieghem NM, et al. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections. Euro Heart J 2018;39:2635-2642.
  2. Leon MB, Smith CR, Mack M, et al. Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery. N Engl J Med 2010;363:1597-1607.
  3. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients. N Engl J Med 2011;364:2187-2198.
  4. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med 2016;374:1609-1620.
  5. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med 2019;380:1695-1705.
  6. Harky A, Seyedzenouzi G, Sanghavi R, et al. COVID‐19 and its implications on patient selection for TAVI and SAVR: Are we heading into a new era? J Card Surg 2021;36:265-267.

Overall, the reported patient benefits of TAVI vs SAVR are:

  • Shorter length of in-hospital stay and quicker discharge home (3 vs 7 days for TAVI vs SAVR)1
  • A faster procedure with TAVI vs SAVR (58 vs 208 min)2
  • Improved health status with TAVI vs SAVR (38% vs 13% change from baseline)1
  • Improved 6-minute walk distance (+17.2 metres [TAVI] vs -15.2 [SAVR] from baseline)2
  • Comparable complication-rates with TAVI reported at 30 days compared with SAVR1,3

References

  1. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med 2019;380:1695-1705.
  2. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients (Supplementary Appendix). N Engl J Med 2019;380:1695-1705.
  3. Barbanti M, van Mourik MS, Spence MS, et al. Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST-TAVI trial. EuroIntervention 2019;15:147-154.

Patients may define “procedural success” as being able to return home following a rapid return to their baseline mobilization and overall functional status and being able to recover quickly to benefit from the physiological impact of their new valve.1

Patients aged <60 and ≥60 years placed a greater value on attributes that favoured TAVR than SAVR, such as a lower mortality rate, reduced procedural invasiveness, and quicker time to return to normal quality of life associated with TAVI, than the value on the time over which SAVR has been proven to work.2

Patients with ssAS who are of low surgical risk are young with an increased life expectancy, and therefore, long-term valve durability might be a consideration.3

References

  1. Lauck SB, Lewis KB, Borregaard B, et al. “What is the right decision for me?” Integrating patient perspectives through shared decision-making for valvular heart disease therapy. Canadian Journal of Cardiology 2021:S0828282X21001331.
  2. Marsh K, Hawken N, Brookes E, et al. Patient-centered benefit-risk analysis of transcatheter aortic valve replacement. F1000Res 2021;8. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6544076/. Accessed June 2021.
  3. Blackman DJ, Saraf S, MacCarthy PA, et al. Long-Term Durability of Transcatheter Aortic Valve Prostheses. J Am Coll Cardiol 2019;73:537-545.

TAVI offers unique organisational advantages over SAVR since it is minimally invasive with lower complication rates, enabling faster recovery, shorter length of stay and conservation of resources: all of which becomes of critical importance during and in the post-COVID-19 landscape.2,4

Additionally, when the patient pathway is optimised, TAVI-led efficiencies in the management of ssAS patients may have a significant economic benefit.5

Transitioning from SAVR to TAVI presents clear opportunities to improve organisational efficiency by:

  1. minimising procedural time1
  2.  lowering the rates of complications1,3
  3. reducing the length of hospital stay without compromising safety1,6
  4. reducing the rate of re-hospitalisation1,7
  5. shortening waiting lists
  6. lessening demand on rehabilitation beds4

References

  1. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med 2019;380:1695-1705.
  2. Harky A, Seyedzenouzi G, Sanghavi R, et al. COVID‐19 and its implications on patient selection for TAVI and SAVR: Are we heading into a new era? J Card Surg 2021;36:265-267.
  3. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients (Supplementary Appendix). N Engl J Med 2019;380:1695-1705.
  4. Perek B, Olasinska-Wisniewska A, Misterski M, et al. How the COVID-19 pandemic changed treatment of severe aortic stenosis: a single cardiac center experience. J Thorac Dis 2021;13:906-917.
  5. Zhou J, Liew D, Duffy SJ, et al. Cost-effectiveness of transcatheter aortic valve implantation compared to surgical aortic valve replacement in the intermediate surgical risk population. Int J Cardiol 2019;294:17-22.
  6. Wayangankar SA, Elgendy IY, Xiang Q, et al. Length of Stay After Transfemoral Transcatheter Aortic Valve Replacement. J Am Coll Cardiol 2019;12:422-430.
  7. Kolte D, Khera S, Sardar MR, et al. Thirty-Day Readmissions After Transcatheter Aortic Valve Replacement in the United States: Insights From the Nationwide Readmissions Database. Circ Cardiovasc Interv 2017;10. Available from: https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.116.004472. Accessed June 2021.

Many studies have consolidated best practices to develop, implement and evaluate a standardised clinical pathway to facilitate safe discharge home at the earliest time after TAVI. These studies aimed to create clinical pathway protocols that supplement the TAVI procedure with the SAPIEN 3TM  valve.1,2,3

A key part of a minimalist pathway is the heart team, who are invaluable in implementing quality innovation that entails minimalist peri-procedure practices and facilitates early discharge home for patients with ssAS.3

The studies have demonstrated that a minimalist, streamlined TAVI pathway with the Edwards Lifesciences SAPIEN 3TM valve, with rapid remobilisation, allows for next-day discharge home, with reproducible, excellent safety and efficiency outcomes. Next-day discharge and 48h discharge was achieved in 80% and 90% of TAVI patients, respectively, and amid concerns that a minimalist approach may affect safety or clinical efficacy, the composite primary endpoint of all-cause mortality or stroke by 30 days occurred in 2.9% of TAVI patients.1,2,3

References

  1. Barbanti M, van Mourik MS, Spence MS, et al. Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST-TAVI trial. EuroIntervention 2019;15:147-154.
  2. Wood DA, Lauck SB, Cairns JA, et al. The Vancouver 3M (Multidisciplinary, Multimodality, But Minimalist) Clinical Pathway Facilitates Safe Next-Day Discharge Home at Low-, Medium-, and High-Volume Transfemoral Transcatheter Aortic Valve Replacement Centers: The 3M TAVR Study. J Am Coll Cardiol 2019;12:459-469.
  3. Lauck SB, Wood DA, Baumbusch J, et al. Vancouver Transcatheter Aortic Valve Replacement Clinical Pathway: Minimalist Approach, Standardized Care, and Discharge Criteria to Reduce Length of Stay. Circ Cardiovasc Qual Outcomes 2016;9:312-321.

The Edwards Benchmark ProgramTM consolidates clinical best practices into an educational transformation pathway for hospitals and adopts the minimalist TAVI pathway to improve patient outcomes and access to TAVI procedures.1 The Benchmark program™ is a standardised care pathway to achieve consistently excellent outcomes; it is a reproducible and scalable programme designed to optimise the patient pathway from admission to discharge.1

References

  1. Frank D. Insights into the Edwards Benchmark program. :24.

There is an increasing need to simplify the TAVI procedure, and practice recommendations have been adopted to support the patient’s journey from referral to discharge.3 A TAVI efficiency programme focuses on avoiding inessential treatment steps and minimising human resource needs during the procedure.3

As such, metrics for a TAVI efficiency programme encompass patients’ quality of life, clinical outcomes, length of stay, resource utilisation, and cost-effectiveness.4 TAVI efficiency leads to reduced procedural time, shorter ICU and hospital stay, lower resource use and hospital costs, and increased volume of TAVI procedures – conferring an overall cost-saving for TAVI compared with SAVR.1,3

In Edwards Lifesciences, hospitals have a partner that has further consolidated the examples of best practice to create the Edwards BenchmarkTM Programme: an educational standardised care pathway (from admission to discharge) that optimises the clinical pathway with a programme designed to deliver good, reproducible patient outcomes and access, and improved institutional capacity driven by proven best practice.2

References

  1. Zhou J, Liew D, Duffy SJ, et al. Cost-effectiveness of transcatheter aortic valve implantation compared to surgical aortic valve replacement in the intermediate surgical risk population. International Journal of Cardiology 2019;294:17-22.
  2. Frank D. Insights into the Edwards Benchmark program. :24.
  3. Tchetche D, de Biase C, Brochado B, et al. How to Make the TAVI Pathway More Efficient. Interv Cardiol 2019;14:31-33.
  4. Hawkey MC, Lauck SB, Perpetua EM, et al. Transcatheter aortic valve replacement program development: Recommendations for best practice: TAVR: Recommendations for Best Practice. Cathet Cardiovasc Intervent 2014;84:859-867.

Objectives of the Benchmark ProgramTM include:

  • <1% 30-day mortality and stroke
  • >80% next-day discharge home
  • <4% 30-day cardiovascular readmissions

Many European centres have been successfully enrolled into the Benchmark Program™, with consistent reduction in average length of stay and increases in the number of TAVI cases performed per day.1

References

  1. Frank D. Insights into the Edwards Benchmark program. :24.

While TAVI has been found to have higher procedural costs compared with SAVR, driven primarily by the costs associated with the valve, this is offset by a decrease in healthcare resource utilisation. The overall costs (initial procedure and hospitalisation) have been reported to be lower for TAVI than for SAVR: this makes TAVI dominant compared with SAVR from a health economic perspective.1

References

  1. Zhou J, Liew D, Duffy SJ, et al. Cost-effectiveness of transcatheter aortic valve implantation compared to surgical aortic valve replacement in the intermediate surgical risk population. Int J Cardiol 2019;294:17-22.

This content is sponsored by Edwards Lifesciences